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New treatment option for Pulmonary Arterial Hypertension
Official title Spironolactone for Pulmonary Arterial Hypertension
ClinicalTrials.gov ID: NCT01712620
What this study is testing
What is Spironolactone?
Spironolactone is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for pulmonary arterial hypertension.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Background: \- High blood pressure in the lungs, known as pulmonary arterial hypertension (PAH), is a rare disorder. In spite of recent advances in treatment, the death rate remains unacceptably high.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 24 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- 1. WHO Group 1 PH patients on either no medical therapy or stable medical therapy for at least the past 4 weeks (defined as no new PAH-specific...
- mean pulmonary artery pressure of \> 25 mmHg at rest,
- pulmonary capillary wedge pressure of less than or equal to 15 mmHg (or a left ventricular end-diastolic pressure of less than or equal to 12 mmHg)...
- pulmonary vascular resistance of \> 3 Wood units (240 dyn.s.cm\^-5). If clinically indicated at the time of enrollment, then a RHC will be performed...
You likely can't join if
- Patients with WHO Group 1 PH and evidence of right heart failure as defined by:
- NYHA/WHO class IV symptoms and
- Echocardiographic evidence of severe RV dysfunction and
- Clinical evidence of right heart failure which may include, but is not limited to elevated jugular venous pressure, ascites, and lower extremity edema
- Patients with WHO Group 1 pulmonary hypertension and a prior diagnosis of cirrhosis with portal hypertension as evidenced by a history of ascites...
- Patients with WHO Group 1 pulmonary hypertension and evidence of active infection, (HIV patients with two consecutive viral loads of \< 500 on their...
See the full eligibility criteria
- 1. WHO Group 1 PH patients on either no medical therapy or stable medical therapy for at least the past 4 weeks (defined as no new PAH-specific therapy, no change in the dose of current PAH-specific therapy and no...
- mean pulmonary artery pressure of \> 25 mmHg at rest,
- pulmonary capillary wedge pressure of less than or equal to 15 mmHg (or a left ventricular end-diastolic pressure of less than or equal to 12 mmHg) and
- pulmonary vascular resistance of \> 3 Wood units (240 dyn.s.cm\^-5). If clinically indicated at the time of enrollment, then a RHC will be performed at the NIH Clinical Center upon study entry under a procedural...
- Patients with WHO Group 1 PH and evidence of right heart failure as defined by:
- NYHA/WHO class IV symptoms and
- Echocardiographic evidence of severe RV dysfunction and
- Clinical evidence of right heart failure which may include, but is not limited to elevated jugular venous pressure, ascites, and lower extremity edema
- Patients with WHO Group 1 pulmonary hypertension and a prior diagnosis of cirrhosis with portal hypertension as evidenced by a history of ascites, hepatic encephalopathy and/or varices prior to enrollment
- Patients with WHO Group 1 pulmonary hypertension and evidence of active infection, (HIV patients with two consecutive viral loads of \< 500 on their most recent determinations within the past 12 months will be...
- Patients with WHO Group 1 pulmonary hypertension who have taken spironolactone or eplerenone within the last 30 days
- Known or suspected allergy to spironolactone
- Pregnant or breastfeeding women (all women of childbearing potential will be required to have a screening urine or blood pregnancy test)
- Age \<18 years
- Inability to provide informed written consent for participation in the study
- Chronic kidney disease (an estimated glomerular filtration rate of \< 35 mL/min/1.73m\^2 of body surface area)
- Serum potassium at the time of enrollment of \> 5 mEq/L
- Concurrent use of an ACE inhibitor and angiotensin II receptor blocker OR Patients currently taking the maximum recommended dose of an ACE inhibitor or an angiotensin II receptor blocker [For patients taking one of...
- Women currently taking drospirenone-containing oral contraceptives The estimated glomerular filtration rate (eGFR) will be calculated using the IDMS-traceable Modification of Diet in Renal Disease (MDRD) equation and...
- Implanted cardiac pacemaker or defibrillator
- Cochlear Implants
- Ocular foreign body (e.g. metal shavings)
- Embedded shrapnel fragments
- Central nervous system aneurysm clips
- Implanted neural stimulator
- Any implanted device that is incompatible with MRI
- Unsatisfactory performance status as judged by the referring physician such that the subject could not tolerate an MRI scan. Examples of medical conditions that would not be accepted would include unstable angina and...
- people requiring monitored sedation for MRI studies
- people with a condition precluding entry into the scanner (e.g. morbid obesity, claustrophobia, etc.)
- people with severe back-pain or motion disorders who will be unable to tolerate supine positioning within the MRI scanner and hold still for the duration of the examination. EXCLUSION CRITERIA FOR GADOLINIUM BASED MRI...
- History of severe allergic reaction to gadolinium contrast agents despite pre- medication with diphenhydramine and prednisone
- Chronic kidney disease (an estimated glomerular filtration rate of \< 60 mL/min/1.73m\^2 of body surface area)
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.